SEND Implementation User Group Minutes 2014-10-20

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When: 2014-10-20, 10:00am-11:00am EST
Place: Telecon



Participant Attended
Troy Smyrnios X
Lynda Sands
Audrey Walker
Bill Houser
Cheryl Sloan X
Dan Potenta
Debra Oetzman X
Donna Danduone
Frederic Mura
Jennifer Feldmann
Jeff Foy X
Kathy Powers
Kev Martin
Linda Hunt
Lou Ann Kramer
Louis Norton
Marc Ellison
Mike Wasko
Pam Hills-Perry X
Peggy Zorn X
Sarah Obbers X
Tom Ratcliffe
Wenxian Wang


Next meeting: 2014-11-17 10-11am EST

Meetings: 4 week schedule



  • Meeting time/frequency
    • Proposal to shift to 30 mins
    • Spike for 3.1 - ad hoc meetings or one-off increasing scheduled time
  • CCT items - question/answer type items to maybe filter up into wiki? Note sent to Lou Ann/Brandy.



Broadcasting presence of forum capability

  • Additional outlets for socializing forum:
    • (Troy) CDISC: ping Diana on adding to newsletter and adding to the SEND page where IG is posted (links to wiki/forum)
      • 2014-07-28: Pinged
      • 2014-09-22: Maybe try note to general CDISC
      • 2014-10-20: Contact established with right person at CDISC; info sent
    • (Jeff) SOT, Regulatory section: ask about getting an article in one of the quarterly newsletters - main and/or regionals. Jeff will ask on what type of format, etc. they'd expect
      • 2014-09-22: sent request to Regulatory and Safety Evaluation specialty section at SOT
      • 2014-10-20: no word yet
    • (Jeff) ACT: Jeff may know a contact to give a first shot at it
      • 2014-09-22: president of ACT
      • 2014-10-20: ACT meeting in Nov, qtrly newsletter, add mention on industry news website pointing to newsletter - deciding how best to communicate
    • (Jeff) Plug at a SUG - bonus!
    • (Donna) The IQ group ( cold call
      • 2014-07-28: In Progress - Donna spoke to part of board Mahalaya Marshall, who is interested (email, site, etc.?), talking to Maggie Lou
      • 2014-08-25: Pinged again
  • (Troy) Core team item - socialize to core team:
    • Forum as avenue for asking questions / subscribing / etc.
    • News page

Review Forum

  • Organ g/100 g - no addition
  • SRANDOM - no addition
  • VISITDY - for 24 hr, 48 hr timepoints, populate VISITDY as 2 or 1? Technically speaking, it is 2 as shown in the guide; however, this is not how most are populating, which is 1 (in line with reporting). Add an FAQ item to say current status of this issue.
  • Email to add Core item for discussion – PCDTC as shown in example in guide is not realistic. In reality, usually the collected information is dose date + number of planned hours. Lot of extra work to assimilate actual collection date/time from some other system or piece of paper. That is of questionable value. Need FDA feedback.
  • COVAL, COVAL1, COVAL2 - label = "Comment" - definitive label for the next in series? ("Comment1", "Comment2", etc.). Currently, setting all to same label causes validator warning. CCT item to recommend definitively stating how the labels should be set.
    • Debra - add (or check if already added) to add definitive guidance to CDISC notes on this variable

Review News Page


  • For 24-hour, 48-hour timepoints, such as PC timepoints, how should VISITDY be populated?
    • This is currently under discussion, in that VISITDY is being used for both the planned study day (not very useful or typically collected) as well as the reported study day (more useful and likely to be collected, but against the technical definition of VISITDY). Technically speaking, VISITDY should be populated as the planned day on which the finding was scheduled; however, many sponsors are populating VISITDY with the reported day concept simply because that is more valuable for review and apt to be collected.

Action Items

Responsible Task Timeframe
Jeff Ping on SOT Next meeting
Donna Ping on IQ Next meeting
Troy Check on CDISC newsletter addition Next meeting
Troy Add core team item for broadcast Next meeting
Troy Add VISITDY FAQ item Next meeting
Troy Initiate PCDTC discussion with core Next meeting
Debra Get COVAL question as CCT item Next meeting

Last revision by Nicola, 2014-10-21